Colonic CancerINEXANCT03130166
INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Colonic Cancer, run by Herlev and Gentofte Hospital at 2 sites in Denmark.
Trial summary
Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Cancer
- What is being tested?
- Intracorporeal anastomosis and Extracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2018to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev Hospital
Herlev, Copenhagen
Sealand University Hospital
Roskilde
About this study
Official title: Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.
The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.
- Conditions
- Colonic Cancer
- Being tested
- Intracorporeal anastomosis, Extracorporeal anastomosis
- Keywords
- Postoperative pain, Postoperative recovery, Intracorporeal anastomosis, Robotic right colectomy
- Medical subject headings
- Colonic Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomosisProcedure or surgery
Use of intracorporeal anastomosis technique
Extracorporeal anastomosisProcedure or surgery
Use of the conventional extracorporeal anastomosis technique
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Patients undergo robotic right colectomy with intracorporeal anastomosis. Receives: Procedure: Intracorporeal anastomosis |
| Extracorporeal anastomosis | Active comparator | Patients undergo robotic right colectomy with extracorporeal anastomosis. Receives: Procedure: Extracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recovery
Questionnaire of Recovery 15 (QoR-15)
Measured: 1 month
Secondary outcomes (12)
Time fo first flatus
Measured: 1 month
Time to first bowel movement
Measured: 1 month
Length of hospital stay
Measured: 1 month
Morbidity
Measured: 1 month
Mortality
Measured: 1 month
Postoperative pain
Measured: 1 month
Heart Rate Variability
Continuously ECG-monitoring intraoperatively and postoperatively
Measured: 2 days
"Timed up and go"-test
Measured: 2 days
Ortostatic hypotension test
Measured: 2 days
Spirometry and PEF - test
Postoperative pulmonary function
Measured: 2 days
Postoperative opioid usage
Measured: 1 month
Whole blood gene expression profiling
Measuring changes in expression of ROS and immulogical genes due to surgery.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 May 2018
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niclas Dohrn, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130166
- Sponsor's protocol ID
- RCT0001
- Acronym
- INEXA
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dohrn N, Oppermann C, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. The effect of intracorporeal versus extracorporeal anastomosis in robotic right colectomy on perianastomotic perfusion: a substudy to a multicenter RCT. Langenbecks Arch Surg. 2022 Dec;407(8):3577-3586. doi: 10.1007/s00423-022-02693-4. Epub 2022 Sep 28.
PubMed 36171282Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13.
PubMed 35129520Dohrn N, Klein MF, Gogenur I. Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial. Dan Med J. 2021 Apr 20;68(5):A09200710.
PubMed 33913415
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03130166
- Acronym / sponsor ID
- INEXA / RCT0001
- Conditions
- Colonic Cancer
- Keywords
- Postoperative pain, Postoperative recovery, Intracorporeal anastomosis, Robotic right colectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.
The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis | Experimental | Procedure: Intracorporeal anastomosisPatients undergo robotic right colectomy with intracorporeal anastomosis. |
| Extracorporeal anastomosis | Active comparator | Procedure: Extracorporeal anastomosisPatients undergo robotic right colectomy with extracorporeal anastomosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracorporeal anastomosisUse of intracorporeal anastomosis technique | Procedure or surgery | Intracorporeal anastomosis |
| Extracorporeal anastomosisUse of the conventional extracorporeal anastomosis technique | Procedure or surgery | Extracorporeal anastomosis |
Primary outcome
Postoperative recovery
Time frame: 1 month
Questionnaire of Recovery 15 (QoR-15)
12 secondary outcomes
Time fo first flatus
Time frame: 1 month
Time to first bowel movement
Time frame: 1 month
Length of hospital stay
Time frame: 1 month
Morbidity
Time frame: 1 month
Mortality
Time frame: 1 month
Postoperative pain
Time frame: 1 month
Heart Rate Variability
Time frame: 2 days
"Timed up and go"-test
Time frame: 2 days
Ortostatic hypotension test
Time frame: 2 days
Spirometry and PEF - test
Time frame: 2 days
Postoperative opioid usage
Time frame: 1 month
Whole blood gene expression profiling
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 36171282Dohrn N, Oppermann C, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. The effect of intracorporeal versus extracorporeal anastomosis in robotic right colectomy on perianastomotic perfusion: a substudy to a multicenter RCT. Langenbecks Arch Surg. 2022 Dec;407(8):3577-3586. doi: 10.1007/s00423-022-02693-4. Epub 2022 Sep 28.
- Derived from this study: PubMed 35129520Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13.
- Derived from this study: PubMed 33913415Dohrn N, Klein MF, Gogenur I. Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial. Dan Med J. 2021 Apr 20;68(5):A09200710.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracorporeal anastomosis and Extracorporeal anastomosis in people with Colonic Cancer, run by Herlev and Gentofte Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recovery (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130166, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.